RTS is an FDA-accredited Third-Party Review Organization (3PRO) that is authorized to review 510(k) submissions for selected low-to-moderate risk medical devices. A 510(k) submitted by a manufacturer to a 3PRO is designated a 3P510k.
RTS was initially accredited by the FDA as a third-party reviewer in 2003. Since then, we have reviewed more 510(k) submissions than any other 3PRO and have consistently conducted more reviews annually than any other 3PRO in the industry. RTS is subject to an FDA audit every three years.
The FDA created the Third Party Review Program in 1997 to provide medical device manufacturers with an alternative path to getting their products approved for sale in the United States.
The program allows a manufacturer to submit a 510(k) directly to a 3PRO such as RTS instead of to the FDA. RTS utilizes the same review criteria employed by the FDA to review the 510(k) submission, which typically takes us about 14 days to complete. We then forward the original 510(k) submission along with our review and a recommendation of either “Substantially Equivalent” (SE) or “Not Substantially Equivalent” (NSE) to the FDA. The Agency is committed to providing a decision on our recommendation within 30 days.
The whole process takes about half the 90-day period the FDA is permitted when it reviews a Traditional 510(k) submission sent in to the FDA directly by a medical device manufacturer.
Approximately 50% of the 510(k)s received by the FDA are eligible for review by a 3PRO. The 510(k) submitter pays the 3PRO for conducting the review; there is no separate payment owed to the FDA.
To determine if your device is eligible for 3PRO review, visit this FDA Product Classification website, enter your “Device,” check the “Third Party Eligible” box, and press the “Search” button.
Contact the FDA 3P Staff.
RTS = Expedited 510(k) Clearances.
RTS = Speed to Market.
RTS is the fastest.
RTS is the most experienced.
RTS has a solid customer retention.
RTS = Satisfied Clients Around the World
RTS 510(k) Review Experience since 2003
Anesthesiology Division
- Anesthesia Vaporizers
- Anesthetic Conduction Catheters
- Breathing-Circuit Bacterial Filters
- Carbon-Monoxide Gas Analyzers
- Diagnostic Spirometers
- Esophageal Stethoscope with Electrical Conductors
- Nebulizers
- Non-Rebreathing Valves
- Patient Care Suction Apparatuses
- Portable Liquid-Oxygen Units
- Portable Oxygen Generators
- Pulmonary Function Predicted Value Calculators
- Tracheal Tubes (w/wo Connectors)
- Ventilatory Effort Recorders
- …
Cardiovascular
- Angiographic, Injectors and Syringes
- Automated External Defibrillator Systems (RTS is no longer accepting reviews for this device type)
- Balloon Inflation Syringes
- Blood Pressure Computers
- Blood Pressure Cuffs
- Catheter Introducers
- Catheter Tip Pressure Transducers
- Cardiovascular Blood Flow Meters
- Cardiac Monitors (Including Cardiotachometer & Rate Alarm)
- Compressible Limb Sleeves
- Continuous Flush Catheters
- Diagnostic Programmable Computers
- Electrocardiographs
- Electrocardiographs, Telephone Transmitters and Receivers
- Embolectomy Catheters / Aspiration Thrombectomy Catheters (RTS is no longer accepting reviews for this device type)
- Electronic Stethoscopes
- Electronic Clinical Thermometers
- Electrosurgical Cutting And Coagulation Device And Accessories
- Guidewires
- Hydraulic Pneumatic or Photoelectric Plethysmographs
- Impedance Plethysmographs
- Intraluminal Artery Strippers
- Intravascular Diagnostic Catheters
- Multi-Function Electrocardiograph Electrodes (RTS is no longer accepting reviews for this device type)
- Non-Invasive Blood-Pressure Measurement Systems
- Medical cathode ray tube displays
- Medical magnetic tape recorders
- Neurovascular guidewire catheters
- Neurovascular percutaneous catheters
- Patient Care Suction Apparatus
- Percutaneous catheters
- Peripheral Mechanical Thrombectomy with Aspiration Devices (RTS is no longer accepting reviews for this device type)
- Percutaneous Retrieval Devices
- Percutaneous Catheters For Cutting or Scoring (RTS is no longer accepting reviews for this device type)
- Physiological Patient Monitors without Arrhythmia Detection or Alarms
- Physiological Monitors Network and Communication Systems (RTS is no longer accepting reviews for this device type)
- Radio Frequency Physiological Signal Transmitters and Receivers
- Steerable Catheters
- Thermal Regulating Systems
- Transluminal Angioplasty Peripheral Catheters
- Vascular Clamps
- Vessel Dilators for Percutaneous Catheterization
- …
Clinical Chemistry
- Predictive Pulmonary-Function Value Calculator
- Blood Specimen Collection Device
- …
Dental
- Calcium Hydroxide Cavity Liners
- Caries Detection Device
- Cavity Varnishes
- Dental Cements
- Extraoral Source X-Ray Systems
- Impression Material
- Intraoral Devices For Snoring and Obstructive Sleep Apnea
- Optical Impression Systems for CAD/CAM
- Orthodontic Plastic Brackets, Ceramic
- Orthodontic Plastic Brackets, Plastic Sequential Aligners
- OTC Denture Reliners
- Porcelain Powder For Clinical Use
- Resin Tooth Bonding Agents
- Root Canal Filling Resin
- Tooth Shade Resin Materials
- Ultraviolet Activator for Polymerization
- Ultrasonic Scalers
- …
Ear, Nose & Throat
- Auditory Impedance Testers
- Bronchoscope Accessories
- Bronchoscopes (Flexible or Rigid)
- Nasopharyngoscopes (Flexible or Rigid)
- Nystagmographs
- Calibrator, Hearing Aid / Earphone and Analysis Systems
- Tinnitus Maskers
- …
Gastroenterology/Urology
- Endoilluminators
- Electrosurgical, Cutting & Coagulation Devices & Accessories
- Endoscope and Accessories
- Endoscopic Electrosurgical Unit And Accessories
- Feeding Tubes (RTS is no longer accepting reviews for this device type)
- Gastrointestinal Tube and Accessories (RTS is no longer accepting reviews for this device type)
- Gastroenterology-urology Biopsy Instruments
- Gastroenterology-urology Endoscopic Guidewire (RTS is no longer accepting reviews for this device type)
- Hemodialysis System and Accessories (RTS is no longer accepting reviews for this device type)
- Led Light Source (RTS is no longer accepting reviews for this device type)
- Light Source, Fiberoptic, Routine (RTS is no longer accepting reviews for this device type)
- Straight Catheters
- Urological Catheters and Accessories
- Urological Catheters and Accessories, Urinary Catheter Kit, Excludes HIV Testing
- …
General Hospital
- Antistick Syringes
- Electronic Clinical Thermometers
- I.V. Containers
- Fluid Transfer I.V. Sets
- Intravascular Administration Sets
- Medical Recirculating Air Cleaners
- Neonatal Phototherapy Units
- Patient Lubricant
- Piston Syringes
- Physical/Chemical Sterilization Process Indicators
- Polymer Patient Examination Gloves
- Sharps Containers
- Short-term (<30 days) Intravascular Therapeutic Catheters
- Single Lumen Hypodermic Needles
- Steam Sterilizers
- Stopcock, I.V. Sets
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Surgical Drapes
- Surgical Gowns (RTS is no longer accepting reviews for this device type)
- Surgical Masks
- Surgical Sponge Counters
- Syringe Needle Introducers
- Vinyl Patient Examination Gloves
- …
General & Plastic Surgery
- AC-Powered Portable Suction Ward Use Apparatus
- Biopsy Instruments
- Ceiling Mounted Surgical Lights (RTS is no longer accepting reviews for this device type)
- Cryosurgical Units & Accessories
- Electrosurgical Coagulation Systems for Aesthetic Use
- Electrosurgical, Cutting & Coagulation & Accessories
- Fat Reducing Low Level Laser
- General & Plastic Surgery Laparoscopes
- Lipoplasty Suction System for Removal
- Microwave Ablation System and Accessories
- Negative Pressure Wound Therapy, Powered Suction Pump (RTS is no longer accepting reviews for this device type)
- Portable Aspiration Pump (Manual or Powered)
- Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Powered Laser Surgical Instruments
- Powered Light Based, Non-Laser Surgical Instruments
- Radiological Image Processing Systems
- Surgical Devices for Cutting, Coagulation, and/or Tissue Ablation, including Cardiac Tissue
- Surgical Exhaust Apparatuses
- Electrosurgical Patient Return Electrodes
- Ultraviolet Dermatological Lights
- …
Microbiology
- Epstein-Barr Virus Serological Reagents
- Microbiological Specimen Collection And Transport Devices
- Transport Culture Media
- …
Neurology
- AC-Powered Goniometers (RTS is no longer accepting reviews for this device type)
- Cortical Electrodes
- Cutaneous Electrodes
- Depth Electrodes
- Diagnostic Electromyographs
- Electroencephalographs
- Electroencephalograph Burst Suppression Detection Software (RTS is no longer accepting reviews for this device type)
- External Functional Neuromuscular Stimulators
- Intracranial Pressure Monitoring Devices
- Full-Montage Standard Electroencephalographs
- Neurological Biofeedback Devices (RTS is no longer accepting reviews for this device type)
- Neurological Endoscopes (RTS is no longer accepting reviews for this device type)
- Neurosurgical Paddles
- Non-Normalizing Quantitative Electroencephalograph Softwares
- Nystagmographs
- Physiological Signal Amplifiers
- Powered Inflatable Tube Massagers
- Powered Temperature Measurement Devices
- Self-retaining Retractors for Neurosurgery
- Standard Polysomnograph With Electroencephalographs
- Radiofrequency Lesion Probes
- Transcutaneous Electrical Nerve Stimulator for Pain Relief
- Ventricular Cannulae (RTS is no longer accepting reviews for this device type)
- …
Ophthalmic Devices
- Ophthalmic Image Management Systems
- Battery-Powered Ophthalmoscopes
- AC-Powered Slit-Lamps Biomicroscopes
- Intraocular Lens Folders and Injectors
- …
Orthopedics
- Arthroscopes
- Orthopedic Stereotaxic Instruments (RTS is no longer accepting reviews for this device type)
- Neurological Stereotaxic Instruments (RTS is no longer accepting reviews for this device type)
- …
Physical Medicine
- Diagnostic Electromyographs
- Infrared Lamps
- Mechanical Wheelchairs
- Powered Inflatable Tube Massagers
- Powered Muscle Stimulators
- Power Traction Equipments
- Powered Wheelchairs
- Powered Wheeled Stretchers
- …
Radiology
- Cardiovascular Blood Flowmeters
- Computed Tomography
- Extraoral Source Digital X-Ray Systems
- Linear Medical Accelerator (RTS is no longer accepting reviews for this device type)
- Mammographic X-Ray Systems
- Magnetic Resonance Imaging Systems
- Magnetic Resonance Specialty Coils
- Magnetic Resonance Spectroscopic Systems
- Scintillation (Gamma) Cameras
- Radiological Image Processing Systems
- Ophthalmic Image Management Systems
- Ultrasonic Diagnostic Transducer
- Ultrasonic Pulsed Doppler Imaging System
- Ultrasonic Pulsed Echo Imaging System
- Extraoral X -Ray Units with Timers
- X-Ray Cabinet Systems
- X-Ray Image-Intensified Fluoroscopic Systems
- X-Ray Mobile Systems
- X-Ray Solid State Imagers, Flat Panel/Digital Imagers
- X-Ray Stationary Systems
- …
Toxicology
- Carbon Monoxide Gas Analyzers
- …
Why did the FDA establish Third-Party Review Program?
To enable the Agency to focus more of its resources on higher risk devices.
To enable the Agency to focus more of its resources on more complex devices.
To enhance speed to market for manufacturers of lower risk and less complex devices.
Key Dates in FDA’s Oversight of Medical Devices
1938 – The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the FDA to bring charges against manufacturers whose medical devices are deemed to be unsafe or defective and against statements, designs, or labeling the agency believes are false or misleading.
1976 – The Medical Device Amendments to the FD&C Act of 1938 allows the FDA to approve medical devices before they are sold in the United States.
1997 – The Food and Drug Administration Modernization Act allows FDA-approved third parties to review 510(k) premarket notification submissions for certain low-to-moderate risk devices, prepare a written review of such submissions, and the forward the reviews, submissions and a recommendation of Substantial Equivalence or Non-equivalence to the FDA for a final determination.
2003 – The FDA authorizes RTS to serve as a 3PRO.
2017 – The FDA Reauthorization Act of 2017 authorizes the FDA to tailor the list of devices eligible for review by 3P Review Organizations. Previously, some complex devices that were ill-suited for the program were 3P review-eligible while other less complex devices that were good candidates for the program were ineligible.
2018 – The FDA publishes 510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.
2018 – FDA announces a plan to eliminate the routine re-review of 510(k) submissions previously reviewed by a 3PRO and to rely solely on the review and recommendation of the 3P Review Organization, all with a goal of reducing the period of time a 3PRO-reviewed submission takes to be approved by the FDA.
2020 – The FDA finalizes the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.
2020 – The FDA re-authorizes RTS to serve as a 3PRO.